drugset / Trial / NCT03620578

DA-EPOCH-R Induction Followed by Nivolumab Consolidation in Newly Diagnosed MYC, BCL2 and/or BCL6 Rearranged HGBL

NCT03620578 ↗

Phase 2 Active not recruiting 97 enrolled HOVON Foundation
NaSingle-groupOpen-labelTreatment

Summary

The prognosis of patients with "high-grade B cell lymphoma with cellular myelocytomatosis (MYC) and B cell lymphoma 2 (BCL2) and/or B cell lymphoma 6 (BCL6) rearrangements" (double hit (DH)/triple hit (TH)-HGBL) with rituximab-CHOP (R-CHOP) is dismal as compared to patients with diffuse large B cell lymphoma (DLBCL) without MYC, BCL2 and/or BCL6 rearrangements. Currently, there is no other standard first line treatment for these patients. Dose Adjusted - Etoposide Prednisone Vincristine Cyclophosphamide Doxorubicin - Rituximab (DA-EPOCH-R) and nivolumab are both feasible treatments. Nivolumab may induce auto-immune reactions. DA-EPOCH-R may induce more hematological toxicity than R-CHOP. The hypothesis is that addition of nivolumab to DA-EPOCH-R will contribute to increased survival.

Timeline

Start
2018-08-01
Primary completion
2024-01-30
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — —
Subject Doxorubicin Other / unclassified — —
Subject Etoposide Small molecule — —
Subject Nivolumab Monoclonal antibody — —
Subject Prednisone Other / unclassified — —
Subject Rituximab Monoclonal antibody — —
Subject Vincristine Small molecule — —